Life Cycle Management of Marketing Authorizations (MAs):
Manage MAs throughout their life cycle, focusing on major markets like EU, US, Canada, Japan, Australia, Brazil, China.
New Submissions and Planning:
Plan and execute new submissions in Most of World (MoW) regions as per set targets.
MA Transfers:
Responsible for transferring MAs and maintaining product history within defined timelines and processes.
CMC Documentation:
Author and organize high-quality CMC documentation (dossiers) for health authority submissions, ensuring technical congruency, regulatory compliance, and meeting e-publishing requirements.
Variations Submissions:
Handle work-sharing and super grouping variations submissions.
CMC Responses:
Prepare CMC responses to health authority questions during development, registration, and throughout the product lifecycle.
Regulatory Evaluation:
Evaluate change controls and other quality events for regulatory impact, including administrative changes.
Minimum Requirements
Experience in regulatory affairs, specifically in CMC documentation and submissions.
Familiarity with international regulations, especially in major markets.
Strong organizational skills and ability to manage multiple projects.
Excellent communication skills and ability to work effectively in a team.
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